AZATRIL 200 mg / 5 ml 20 ml suspension

1. What Azatril is and what it is used for1. What Azatril is and what it is used for
Azatril is an antibacterial product from the group of macrolides. It kills bacteria,
causing infections by disrupting the formation of proteins in their cell wall.
Azatril is indicated for the treatment of infections caused by antibiotic-sensitive microorganisms such as:• infections of the upper (sinus and middle ear inflammations, tonsillopharyngitis) and lower respiratory tract (bronchitis, some types of pneumonia);• skin and soft tissue infections (erysipelas, impetigo and secondary pyoderma, first stage Lyme disease);• sexually transmitted diseases - uncomplicated urethritis and cervicitis caused by chlamydia; gonococcal urethritis and cervicitis;• peptic ulcer disease and chronic inflammation of the lining of the stomach and duodenum, to eliminate and destroy Helicobacter pylori infection.
2. What you need to know before you take Azatril
Do not take Azatril- if you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics or any of the other ingredients of this medicine (listed in section 6). Allergic reactions can cause skin rashes and wheezing
Warnings and precautionsTalk to your doctor or pharmacist before taking Azatril if:- you have severe liver or kidney problems- you have severe heart problems (heart failure) and heart rhythm problems, such as Prolonged QT syndrome (seen on an electrocardiogram) or a very slow heart rate- the balance of salts in your body is disturbed and especially if the levels of potassium or magnesium in your blood are too low- you are taking some ergotamine derivatives, such as ergotamine (for migraine treatment) as these medicines should not be taken at the same time as azithromycin (see section “Other medicines and Azatril”)- you have a certain type of muscle weakness called myasthenia gravis- you are taking medicines that cause abnormal changes in the electrocardiogram (see section "Other medicines and Azatril").
If allergic symptoms occur, stop taking Azatril and contact your doctor immediately.
Tell your doctor if you experience palpitations or irregular heartbeats, or feel dizzy or weak while taking Azatril.
Diarrhea may occur while taking all antibiotics (including Azatril) or even a few weeks after you stop taking them. If it becomes severe or very long, or if you notice that your stools contain blood or mucus, stop taking Azatril immediately, as this condition can be life-threatening. Do not take medicines that stop or slow down peristalsis and contact your doctor.
Other medicines and AzatrilTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Be sure to tell your doctor if you are taking any of the medicines listed below. Concomitant use with azithromycin is not recommended as it may cause severe heart problems (visible on the electrocardiogram):- drugs that may affect heart rhythm (eg quinidine, procainamide, hydroquinidine, disopyramide, amiodarone, sotalol, dofetil , ibutilide)- antibacterial agents from the group of fluoroquinolones - moxifloxacin, levofloxacin- pimozide - used to treat mental health problems- cisapride - used to treat stomach problems - terfenadine - used to treat hay fever- citalo of depression
Tell your doctor if you are taking any of the following medicines:- antacids - used for heartburn and indigestion. Azatril should be taken at least 1 hour before or 2 hours after the antacid.- digoxin - used for heart problems. Your doctor may adjust your dose.- colchicine (used for gout and familial Mediterranean fever)- ergotamine - (used for migraines) should not be taken at the same time as azithromycin, as serious side effects (with stiffness or tingling sensation in the limbs) may occur , muscle spasms, headaches, seizures, abdominal or chest pain)- medicines to lower blood cholesterol (statins)- warfarin or similar drugs - used to thin the blood. Azithromycin may cause further thinning of the blood.- zidovudine or nelfinavir - used to treat HIV infections. When you take nelfinavir with azithromycin, you may get more of the side effects described in this leaflet- rifabutin - used to treat tuberculosis- cyclosporine - used to prevent the rejection of a transplanted organ from your body. Your doctor will check your cyclosporine levels regularly and may change your dose.
Azatril with food, drink and alcoholAzatril should be taken at least 1 hour before or 2 hours after a meal.
Pregnancy, breast-feeding and fertilityIf you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is insufficient information on the use of azithromycin during pregnancy, therefore you should not use azithromycin during pregnancy unless specifically recommended by your doctor.
Azithromycin is partially excreted in breast milk, so it should not be used if you are breast-feeding.
Driving and using machinesThere are no data on the effect of azithromycin on the ability to drive and use machines. However, azithromycin can cause dizziness and seizures, so you should make sure you are not affected before driving or using machines.
Azatril contains sucrose, methyl parahydroxybenzoate and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Methyl parahydroxybenzoate may cause allergic reactions (probably of the delayed type). A 5 ml suspension of this medicine contains 138 mg (6 mmol) of sodium (the main ingredient in table salt). This amount is equivalent to 7% of the recommended maximum daily sodium intake for an adult. This should be taken into consideration by patients on a controlled sodium diet.
3. How to take Azatril
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.
PosologyAdultsIn uncomplicated urethritis and cervicitis caused by chlamydia, the dose is 1 g taken as a single dose.
For all other indications, the total dose is 1.5 g, spread over 500 mg on three consecutive days. Alternatively, the same dose is taken for 5 days, with 500 mg administered on the first day and 250 mg on the remaining days.
Elderly patientsDose is administered as in adult patients. They are more likely to develop severe heart rhythm problems and heart problems, so they should be monitored by a doctor.
ChildrenIn children weighing less than 45 kg, the capsule form of Azatril is not suitable for use. Azatril powder for oral suspension should be used. No data are available in children under 6 months of age. The dose in children is 10 mg / kg once daily for 3 days.
The following dosing regimens are usually used:For upper and lower respiratory tract infections and skin and soft tissue infections (excluding erythema migrans) - 10 mg / kg for 24 hours once daily for 3 days.
Doses of the product are determined by body weight.
Body weight Azatril powder for oral suspension 100 mg / 5 mlAzatril powder for oral suspension 200 mg / 5 ml5 kg 2.5 ml (50 mg)  6 kg 3 ml (60 mg)  7 kg 3.5 ml (70 mg)  8 kg 4 ml (80 mg)  9 kg 4.5 ml (90 mg)  10-14 kg 5 ml (100 mg)  15-24 kg 5 ml (1 tablespoon - 200 mg)25-34 kg 7.5 mg (1 large and 1 small spoon - 300 mg)35-44 kg 10 ml (2 tablespoons - 400 mg)over 45 kg The dosage for adults is 500 mg dailyIn the treatment of streptococcal pharyngitis in children, Azatril is administered once daily at a dose of 10 mg / kg or 20 mg / kg for 3 days. However, penicillin is the drug of choice in the prevention of pharyngitis caused by Streptococcus pyogenes and exacerbated rheumatism with fever.
In migraine erythema, the total dose is 60 mg / kg: the first day 20 mg / kg once daily, followed by 10 mg / kg for 2 to 5 days in a single dose.
In infections of the stomach and duodenum caused by Helicobacter pylori -20 mg / kg daily in combination with appropriate drugs at the discretion of the physician.
Renal impairmentNo dose adjustment is required in patients with mild to moderate renal impairment. Caution should be exercised when administering azithromycin to patients with severe renal impairment.
Hepatic impairmentUse with caution in patients suffering from severe liver disease.
Dosage in elderly patients:For elderly patients the dosage is the same as that used in adult patients. They are more likely to develop severe heart rhythm problems and heart problems, so they should be monitored by a doctor.
Method of administrationAzatril is administered once daily, at least 1 hour before or 2 hours after a meal. The exact dosage is measured using an oral dosing syringe or a measuring spoon.
Add 12 ml of pre-boiled and cooled water to the bottle and then shake well to obtain a homogeneous suspension. The suspension should be shaken before each use.
If you take more Azatril thanyou should If you take too much Azatril, contact your doctor, pharmacist or go to the nearest hospital straight away.
Symptoms of overdose may include hearing loss, nausea and diarrhea. In case of overdose, hospital admission may be required.
If you forget to take AzatrilIf you forget to take Azatril, take your dose as soon as possible. If it is almost time for your next dose, skip this dose and take the next one at the correct time. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you miss a dose, you need to take the full amount that has been prescribed for you. This means that you will complete the course of treatment one day later.
Do not take a double dose to make up for a forgotten dose.
If you stop taking AzatrilNever stop taking Azatril at your discretion, but discuss this with your doctor first. If the prescribed treatment is not completely completed, the infection may recur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following symptoms of severe allergic reactions, stop taking this medicine and tell your doctor immediately or go to the emergency department of the nearest hospital:- Sudden difficulty breathing, speaking and swallowing- Swelling of the lips, tongue, face and neck- Severe dizziness or collapse- Severe or itchy skin rash, especially if blisters and inflammation of the eyes, mouth or genitals occur.- Skin rash, fever, swollen glands, increased appearance of white blood cells (eosinophilia) and inflammation of the internal organs (liver, lungs, heart, kidneys and colon), as these may be signs of a hypersensitivity reaction (drug reaction with eosinophilia and systemic symptoms (DRESS))- Contact a doctor immediately if you get a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse reaction is unknown (cannot be estimated from the available data).
If you get any of the following side effects, contact your doctor immediately:- Severe prolonged or bloody diarrhea accompanied by stomach pain or fever. This may be a sign of severe inflammation of the gut and may be seen in rare cases when taking antibiotics. '- Yellowing of the skin or eyes caused by liver problems- Inflammation of the pancreas (pancreas), which can cause severe pain in the abdomen and back.- Increased or decreased production of urine or traces of blood in the urine.- Skin rash caused by sensitivity to sunlight- Abnormal bruising or bleeding- Irregular heartbeat
These are serious side effects. You may need urgent medical attention. Serious side effects are uncommon (may affect up to 1 in 100 people) or their frequency cannot be determined from the available data.
The following side effects are grouped by frequency:
Very common (may affect more than 1 in 10 people)- diarrhea
Common (may affect up to 1 in 10 people):- headache- nausea, vomiting, abdominal pain- change in the number of white blood cells and the concentration of bicarbonate in the blood
Uncommon (may affect up to 1 in 100 people):- decrease in the number of white blood cells and increased number of eosinophils in the blood- thrush (candidiasis) - infection in the oral cavity caused by a fungus- inflammation of the vagina from infection (vaginitis) - pneumonia- infections caused by fungi- bacterial infection- sore throat (pharyngitis)- inflammation of the gastrointestinal tract (gastroenteritis)shortness of breath, chest pain, wheezing and coughing (respiratory disorders)- inflammation of the nasal mucosa (rhinitis)- angioedema (severe allergic reaction that causes swelling of the face or throat)- hypersensitivity lack of appetite (anorexia) - nervousness insomnia dizziness drowsiness- tingling and tingling (paresthesia)- taste disturbance (dysgeusia)- visual disturbances- hearing impairment, incl. with dizziness (vertigo) - auditory disturbances heartbeat (palpitations)- hot flushes shortness of breath- nosebleeds constipation- bloating indigestion- inflammation of the stomach lining (gastritis) - difficulty swallowing gastric distension dry mouth belching- ulceration of the oral cavity- increased salivation- rash- itching- urticaria- inflammation of the skin (dermatitis)- dry skin- increased sweating- pain, swelling and limited joint movement (osteoarthritis)- muscle pain back pain neck pain- painful or difficult urination- low back pain (kidney pain)- heavy menstrual bleeding- testicular disorders- fatigue- facial swelling- chest pain- fever- pain, tingling, muscle weakness- swelling (swelling), swelling of the limbs (peripheral edema)- physical malaise- weakness (asthenia)- elevated liver enzymes, bilirubin, urea, creatinine, chlorine, alkaline phosphatase, blood sugar, platelets , bicarbonates in the blood- deviations in the values ​​of potassium in the blood - post-procedural complications
Rare (may affect up to 1 in 1,000 people):- agitation- jaundice- impaired liver function- photosensitivity reactions
Not known (frequency cannot be determined from the available data)- decreased platelet count- reduced number of red blood cells due to destruction (haemolytic anemia)- intestinal infection of the colon (pseudomembranous colitis)- anaphylactic reaction life-threatening allergic reaction)- feeling anxious, aggression, confusion, anxiety, disorientation (delirium)- seeing and hearing things that do not exist (hallucinations)- weakened sensation when touched (hypoaesthesia)- fainting with temporary loss of consciousness (syncope) seizures- a feeling of overactivity- impaired sense of smell or loss of sense of smell (parosmia, anosmia)- loss of taste (ageusia)- exacerbation or worsening of muscle weakness (myasthenia gravis)- hearing impairment, incl. deafness and / or tinnitus- rapid (ventricular tachycardia) or irregular heartbeat, which are sometimes life-threatening, change in heart rhythm detected on an electrocardiogram (torsades de pointes), changes in the electrocardiogram- low blood pressure- inflammation of the pancreas )- change in the color of the tongue- liver disorders, which in some cases can be fatal (liver failure, fulminant hepatitis, liver necrosis))- severe, life-threatening skin reactions with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome, toxic epidermal necrolysis), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous EP pustulosis ) - severe redness of the skin- joint pain- acute renal failure- inflammation of the kidneys (interstitial nephritis)
The following side effects have been reported with prophylactic treatment against Mycobacterium Avium complex (MAC):
Very common (may affect more than 1 in 10 people) - diarrhea- abdominal pain- nausea- gas (flatulence)- abdominal discomfort- watery stools
Common (may affect up to 1 in 10 people):- loss of appetite (anorexia)- dizziness headache- tingling or numbness (paresthesia)- changes in taste- visual disturbances- deafness- rash, itching- joint pain (arthralgia) )- fatigue
Uncommon (may affect up to 1 in 100 people):- decreased sensitivity to touch (hypoaesthesia) - hearing loss and tinnitus palpitations- liver inflammation (hepatitis)- sensitivity to sunlight, severe skin disease with the formation of blisters on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome) - general malaise weakness (asthenia)
5. How to store Azatril
Store below 25 ° C.
Keep out of reach of children.Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.
Shelf life of the finished suspension - 5 days when stored from 2 ° C to 8 ° C (in a refrigerator)
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What Azatril contains:The active substance is azithromycin dihydrate, equivalent to 100 mg or 200 mg azithromycin in a 5 ml suspension.
The other ingredients are: disodium phosphate dihydrate; banana essence; saccharin sodium; xanthan gum; mannitol; methyl parahydroxybenzoate; sodium cyclamate; pregelatinized starch; trisodium phosphate anhydrous; sucrose.
What Azatril looks like and contents of the packDescriptionWhite to off-white powder for oral suspension. Package
Azatril 15 g powder for 20 ml oral suspension in brown glass bottles, a double dosing spoon and a syringe for oral dosing.
Marketing Authorization HolderAlvogen Pharma Trading Europe EOODBul. Bulgaria № 86, fl. 1Sofia 1680Bulgaria